اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
AMBRISENTAN از شرکت ZYDUS PHARMS
Abbreviated New Drug Application (ANDA): 210058
Company: ZYDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription |
AB |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/28/2019 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210058Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/08/2021 | SUPPL-6 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 12/22/2020 | SUPPL-5 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 02/14/2020 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/20/2020 | SUPPL-3 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 12/09/2019 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/09/2019 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
AMBRISENTAN
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210715 | CIPLA |
| AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 208441 | MYLAN |
| AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 209509 | PAR PHARM INC |
| AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 208354 | SIGMAPHARM LABS LLC |
| AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210784 | SUN PHARM |
| AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 208252 | WATSON LABS INC |
| AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210058 | ZYDUS PHARMS |
| LETAIRIS | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | Yes | AB | 022081 | GILEAD |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 210715 | CIPLA |
| AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208441 | MYLAN |
| AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 209509 | PAR PHARM INC |
| AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208354 | SIGMAPHARM LABS LLC |
| AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 210784 | SUN PHARM |
| AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208252 | WATSON LABS INC |
| AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 210058 | ZYDUS PHARMS |
| LETAIRIS | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | Yes | AB | 022081 | GILEAD |
منبع : www.accessdata.fda.gov
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